Method and device for delivering a subcutaneous dose through multiple injections

ABSTRACT

A method of administering subcutaneous treatment to a patient is provided. The method includes delivering, by a needle-free injection device, a first volume of a treatment at a first location on a surface of a body of the patient; detecting a movement of the needle-free injection device relative to the first location; determining, from the movement of the needle-free injection device relative to the first location, a second location of the needle-free injection device relative to the first location; determining a second volume of the treatment to deliver at the surface of the body of the patient at the second location; and delivering, by the needle-free injection device, the second volume of the treatment at the second location on the surface of the body of the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application Ser. No. 62/427,575, titled “METHOD AND DEVICEFOR DELIVERING A SUBCUTANEOUS DOSE THROUGH MULTIPLE INJECTIONS,” filedNov. 29, 2016, which is incorporated herein by reference in itsentirety.

BACKGROUND Technical Field

The application relates generally to administering a dose of medicinevia multiple injections, and more particularly, in one aspect, tosystems and methods for tracking and controlling an amount of treatmentinjected by a needle-free injector at multiple sites on a patient.

SUMMARY

The methods and devices described herein overcome drawbacks of knownapproaches by controllably injecting a known volume of a treatment atmultiple sites on the body to a controllable depth, including tointradermal, subdermal, or intramuscular treatment sites. In theembodiments described, a needle-free injector is used. As a user (e.g.,a physician) moves the needle-free injector around a treatment site, theinjector tracks its position and movement, for example, from the outputof an accelerometer, gyroscope, and/or barometric sensor. This allowsthe injector to track the amount of treatment delivered at each locationin a treatment “grid” or other treatment area. At each potentialtreatment location to which the injector is moved, the injector candetermine an appropriate amount of treatment, if any, to be administeredthere based on prior injections of the current dose or earlier doses,the characteristics of the location, or other factors. The injector canthen controllably deliver the treatment at the location or, alternately,restrain the actuator from delivering treatment at the location.

In some embodiments, an imaging sensor, such as a camera or sonogramdevice, may also be used to capture one or more images or sonograms ofthe treatment surface or potential treatment sites in the skin or themuscles beneath it. The images can then be processed to determine orverify the location of the injector. The images may also be used toidentify intradermal, subdermal, or intramuscular treatment sitesrelevant to the treatment.

According to one aspect, a method of administering subcutaneoustreatment to a patient is provided. The method includes delivering, by aneedle-free injection device, a first volume of a treatment at a firstlocation on a surface of a body of the patient; detecting a movement ofthe needle-free injection device relative to the first location;determining, from the movement of the needle-free injection devicerelative to the first location, a second location of the needle-freeinjection device relative to the first location; determining a secondvolume of the treatment to deliver at the surface of the body of thepatient at the second location; and delivering, by the needle-freeinjection device, the second volume of the treatment at the secondlocation on the surface of the body of the patient.

In one embodiment, the act of delivering, by the needle-free injectiondevice, the first and second volumes of the treatment at the first andsecond locations on the surface of the body of the patient includesdelivering the first and second volumes of the treatment to a first andsecond subcutaneous treatment site in the body of the patient. In afurther embodiment, determining the second volume of the treatment isperformed with reference to a previous treatment volume delivered to thesecond subcutaneous treatment site. In a further embodiment, each of thefirst subcutaneous treatment site and the second subcutaneous treatmentsite is one of an intradermal site, a subdermal site, and anintramuscular site.

In one embodiment, the method includes capturing, using a camera of theneedle-free injection device, a first image of the surface of the bodyof the patient, wherein determining the second volume of the treatmentis performed with reference to the first image of the surface of thebody of the patient. In another embodiment, the method includes,responsive to determining that the previous treatment volume exceeds apredetermined value, determining that no treatment should be deliveredto the second subcutaneous treatment site. In a further embodiment, themethod includes disabling an actuator of the needle-free injectiondevice from delivering the treatment to the second subcutaneoustreatment site.

In another embodiment, the method includes capturing, using a camera ofthe needle-free injection device, a first image of the surface of thebody of the patient, wherein determining the second location of theneedle-free injection device relative to the first location is performedwith reference to the first image of the surface of the body of thepatient. In a further embodiment, the method includes identifying, inthe first image of the surface of the body of the patient, the firstlocation; capturing, using the camera of the needle-free injectiondevice, a second image of the surface of the body of the patient; andidentifying, in the second image of the surface of the body of thepatient, the first location. In a still further embodiment, the methodincludes identifying, in the second image of the surface of the body ofthe patient, the second location. In a further embodiment, the secondvolume is determined with reference to a value determined from at leastone of the first image and the second image.

In one embodiment, the act of detecting the movement of the needle-freeinjection device relative to the first location includes determining adisplacement of the needle-free injection device with reference to anoutput of at least one of an accelerometer, a gyroscope, and abarometric sensor.

In another embodiment, the method includes storing, in a memory of theneedle-free injection device, a first location value corresponding tothe first location, and a second location value corresponding to thesecond location. In a further embodiment, the method includes storing,in the memory of the needle-free injection device, a plurality of valuescorresponding to a volume of treatment delivered at each of the firstlocation and the second location. In a still further embodiment, theplurality of values is stored in a representation of an array.

In one embodiment, the method includes storing, in a memory of theneedle-free injection device, a first location value corresponding tothe first subcutaneous treatment site, and a second location valuecorresponding to the second subcutaneous treatment site.

In another embodiment, the method includes providing, via a userinterface of the needle-free injection device, an indication that theneedle-free injection device should be moved from one of the firstlocation and the second location. In a further embodiment, the methodincludes providing, via a user interface of the needle-free injectiondevice, an indication of a velocity at which the needle-free injectiondevice should be moved from the first location to the second location.

In one embodiment, the method includes delivering at least oneadditional volume of the treatment at at least one additional locationon the surface of the body of the patient, wherein the sum of the firstvolume, the second volume, and the at least one additional volume issubstantially equal to a dose of the treatment.

In another embodiment, the method includes providing, by the needle-freeinjection device, an indication that needle-free injection device is atthe second location. In a further embodiment, the indication is at leastone of an audible indication, a visual indication, and a tactileindication.

In another embodiment, the method includes detecting that theneedle-free injection device is substantially motionless at the secondlocation. In yet another embodiment, the method includes providing, bythe needle-free injection device, an indication that the needle-freeinjection device may be moved to a third location on the surface of thebody of the patient. In still another embodiment, the method includesdetermining a distance between the first location and the secondlocation, wherein determining the second volume of the treatment isperformed with reference to the distance. In another embodiment, thetreatment is a first treatment, and the method further includesdelivering, by the needle-free injection device, a first and secondvolume of a second treatment at the respective first and second locationon the surface of the body of the patient.

According to another aspect, a needle-free device for administeringsubcutaneous treatment to a patient is provided. The needle-free deviceincludes an actuator configured to deliver a plurality of volumes of atreatment at a plurality of locations on a surface of a body of thepatient; at least one sensor configured to detect a movement of theneedle-free device from a first location on the surface of the body ofthe patient to a second location on the surface of the body of thepatient; and a processor configured to determine, from the movement ofthe needle-free device relative to the first location, a second locationof the device relative to the first location, and determine a volume ofthe treatment to deliver at the surface of the body of the patient atthe second location.

According to one embodiment, the needle-free device includes a nozzle,wherein the actuator delivers the plurality of volumes of the treatmentsthrough the nozzle. According to a further embodiment, the actuatorincludes at least one of a Lorentz motor and an electromagnetic motor.

According to another embodiment, the processor is configured todetermine the volume of the treatment to deliver at the surface of thebody of the patient with reference to a previous treatment volumedelivered at a subcutaneous treatment site adjacent the second location.According to a further embodiment, the processor is configured todetermine, responsive to the previous treatment volume exceeding apredetermined value, that no treatment should be delivered to thesubcutaneous treatment site. According to a still further embodiment,the processor is configured to prevent the actuator from delivering thetreatment to the subcutaneous treatment site.

According to one embodiment, the needle-free device includes a cameraconfigured to capture a plurality of images of the surface of the bodyof the patient. According to a further embodiment, the processor isconfigured to determine the second location of the needle-free devicerelative to the first location with reference to at least one of theplurality of images. According to a still further embodiment, theprocessor is configured to identify, in a first image of the pluralityof images, the first location; and identify, in a second image of theplurality of images, the first location. In a further embodiment, theprocessor is configured to identify, in the second image of theplurality of images, the second location. In a still further embodiment,the volume is determined with reference to a value determined from atleast one of the first image and the second image.

In one embodiment, the at least one sensor is at least one of anaccelerometer, a gyroscope, and a barometric sensor. In anotherembodiment, the needle-free device includes a memory, wherein theprocessor is further configured to store in the memory a first locationvalue corresponding to the first location and a second location valuecorresponding to the second location. In a still further embodiment, theprocessor is configured to store in the memory a plurality of valuescorresponding to a volume of treatment delivered at each of the firstlocation and the second location. In yet a further embodiment, theprocessor is configured to store the plurality of values in arepresentation of an array.

In another embodiment, the needle-free device includes a plurality ofnozzles, and the actuator delivers the plurality of volumes of thetreatments through the plurality of nozzles.

In one embodiment, the needle-free device includes a user interfaceconfigured to provide an indication that the needle-free device shouldbe moved from one of the first location and the second location. In afurther embodiment, the user interface is configured to provide anindication of a velocity at which the needle-free device should be movedfrom the first location to the second location.

BRIEF DESCRIPTION OF DRAWINGS

Various aspects of at least one embodiment are discussed below withreference to the accompanying figures, which are not intended to bedrawn to scale. The figures are included to provide an illustration anda further understanding of the various aspects and embodiments, and areincorporated in and constitute a part of this specification, but are notintended as a definition of the limits of any particular embodiment. Thedrawings, together with the remainder of the specification, serve toexplain principles and operations of the described and claimed aspectsand embodiments. In the figures, each identical or nearly identicalcomponent that is illustrated in various figures is represented by alike numeral. For purposes of clarity, not every component may belabeled in every figure. In the figures:

FIG. 1 is a block diagram of an injector for delivering a subcutaneousdose through multiple injections according to one or more embodiments;

FIG. 2 is a flow chart of a method for using the injector according toone or more embodiments;

FIG. 3 is a flow chart of another method for using the injectoraccording to one or more embodiments;

FIG. 4A is a representation of a user interface according to one or moreembodiments;

FIG. 4B is a representation of a user interface according to one or moreembodiments;

FIG. 4C is a representation of a user interface according to one or moreembodiments;

FIG. 4D is a representation of a user interface according to one or moreembodiments;

FIG. 5A is a representation of an injector according to one or moreembodiments; and

FIG. 5B is a representation of a single-dose assembly for use in aninjector according to one or more embodiments.

DESCRIPTION

Many treatment regimens call for the injection of large doses of amedicant or other treatment. For example, doses of botulinum toxin maybe administered subcutaneously via hypodermic needle, auto-injector, orneedle-free injector, either to treat muscle disorders or for cosmeticpurposes. Such doses may be 2 to 3 mL, or larger. As another example,dental procedures may call for the administration of large doses of anumbing agent, such as procaine.

To increase their effectiveness and avoid pooling and other localizedproblems, large doses are often administered as a number of smallerinjections. For example, injections may be administered at a number oflocations corresponding to a grid array over a region of the patient'sskin, or may be injected along one or more dimensions of a wrinkle orother feature that is being targeted.

The efficacy of manual injections of a treatment may be limited by anumber of factors. For example, a physician manually actuating aninjector of a hypodermic needle may have, at best, the dexterity tocontrollably administer an injection as small as 10 μL. Even whereprecise volumes of injections can be delivered, a physicianadministering a number of injections in a relatively small region isrequired to manually move the injector a small, precise distance toachieve an appropriate spacing for successive injections, to avoidadministering multiple injections in the same location. The imprecisionof this manual process again introduces accuracy and dexterity issues,and the possibility of inconsistent or suboptimal results.

According to one or more embodiments, methods and systems are providedfor accurately delivering large doses via multiple injections from aneedle-free injector. Such an injector may be used by a medicalprofessional in a medical setting (e.g., a doctor's office) or by thepatient (e.g., in the home). The injector is moved over a treatmentregion on the patient, such as the patient's forehead. A nozzle of theinjector may inject the treatment at multiple locations in the treatmentregion.

The movement and orientation of the injector can be detected via sensorsincluding an accelerometer, a gyroscope, a barometric sensor, or thelike. The amount of movement can be used to determine a current positionof the injector. The volume of treatment injected at each location cantherefore be determined and stored. Because the depth of the injectionis also controllable, it is possible to track the amount of treatmentadministered in three-dimensions. The injector can use this treatmentlocation information to administer a large dose appropriately andprecisely at a number of locations. For example, the total amount of thetreatment previously delivered at a particular location may be used todetermine how much additional treatment, if any, should be administeredat that location. In some embodiments, a camera or sonogram device maybe used to capture images of the treatment region, including thetreatment surface (i.e., the skin through which the treatment will pass)and/or the treatment site (i.e., the subcutaneous location to where thetreatment will be delivered). The images may be examined by the injectorto determine its location in the treatment region, or to identifysurface or subdermal regions for potential administration of treatment.

The injector includes an actuator, which may be a Lorentz-type orelectromagnetic actuator. The actuator may be in communication with acartridge, ampoule, or other receptacle for a treatment, which may be aliquid, a suspension, or a solid, such as a powder. By controlling avelocity and duration of the actuator's motion, the needle-free injectorcan deliver, repeatedly and with precision, an amount of the treatmentto a subcutaneous treatment site in the patient.

The injector also includes at least one sensor, the output of which canbe used to determine a location of the injector with respect to thetreatment surface or treatment site. For example, an accelerometer maybe included in the injector to detect when and how much the injector isaccelerating. This information may be used to determine how far theinjector has been moved, which can in turn be used to determine acurrent location of the injector. As another example, a gyroscope may beincluded in the injector to determine an orientation of the injector,which may be used to determine where the treatment is being delivered.As another example, a barometric sensor may be included in the injectorto detect a current height (i.e., vertical position) of the injector.This information may be used to determine what part of the body (e.g.,head as opposed to calves) will receive a current injection of thetreatment.

In some embodiments, the injector may include an injector assembly thatincorporates a nozzle through which the actuator delivers the treatmentto the treatment site. The injector assembly may also incorporate the atleast one sensor, so that the at least one sensor is near the treatmentsite when the treatment is about to be delivered.

A processor receives the output of the sensors, and uses it to determinethe location of the device relative to a treatment region on the body ofthe patient. For example, the processor may be configured to determinethe current location of the device relative to a first injection of thetreatment, or other reference point. The processor uses this locationinformation to track an amount of treatment delivered at a number oflocations in the treatment site. This information may be used todetermine how much treatment should be delivered at a current locationof the device.

Consider an example where a large dose of 3 mL is administered as anumber of smaller injections of 100 μL at each location in the treatmentsite. As the injector passes over each location in the treatment site,the processor may determine how much, if any, treatment to inject atthat location. For example, on a first pass over a particular location,the processor may direct the actuator to inject 70 μL. On a second passover the location, the processor may direct the actuator to inject only30 μL to reach the total for the location of 100 μL. On a third passover the location, the processor may prevent the actuator from injectingany further treatment at the location.

A user interface may also be provided to inform or direct a user of theinjector. For example, the user interface may instruct the user (e.g., adoctor) to move the injector to a particular location in the treatmentsite, and/or to move the injector at a particular velocity, in aparticular direction, etc. The user interface may also provideinformation to the user about a number of previous injections orsuggested future injections. For example, a “heat map” may be displayed,with locations that have received the full amount of treatment in onecolor (e.g., red), and with locations that require further injections oftreatment displayed in another color (e.g., green). In this way, theuser interface can visually direct the user to move the injector toapply treatments to regions where it is necessary.

The injector may be provided as a device for use in a medical facilityand having permanent reusable components and disposable components. Forexample, the actuator, user interface, and injector assembly may be partof a machine used in treatment/examination rooms by medical personnel.The machine may be configured to receive (e.g., in the injectorassembly) a disposable single-dose assembly having a nozzle connected toan ampoule sized for a single dose of the treatment. The ampoule may bea fluid transport tube holding the treatment, connected at one end tothe nozzle and configured to be removably connected at the other end tothe actuator. In this way, single doses can be quickly and easilyconnected to the actuator to be delivered to a patient, with thesingle-dose assembly of the ampoule and nozzle being disposed ofafterwards. A new single-dose assembly can be attached for use with thenext patient, and so forth. In other embodiments, the injector may beprovided as a handheld device suitable for use in outpatient careapplications or other non-medical settings, such as the patient's home.

FIG. 1 illustrates a block diagram of an injector 100 (e.g., aneedle-free injector) according to one or more embodiments. In theembodiment shown in FIG. 1, the injector 100 includes an actuator 110configured to deliver a treatment (e.g., a liquid or powder) from anampoule 112 to a subcutaneous site of a patient via a nozzle 120. Aprocessor 130 is configured to receive information from a number ofsensors, including an accelerometer 140, a gyroscope 150, a barometricsensor 160, and an imaging sensor 170 (i.e., a camera), and to use thatinformation to determine a current location of the nozzle 120 on atreatment surface (i.e., skin) of the patient. Using that locationinformation, the processor 130 selectively controls the actuator 110 todeliver one or more volumes of the treatment to one or more treatmentsites in the patient. A memory 180 is configured to store locationinformation, as well as information about treatments administered atthose locations.

A user interface 190 is configured to provide one or more indicationsregarding the location or desired movement of the injector 100. Suchindications may be provided in an audible, visual, and/or tactilemanner, and may indicate to the user of the injector that the nozzle 120should be moved from a first location, that the nozzle 120 should bemoved to a second location, that the nozzle 120 should be moved at aparticular velocity, that the nozzle 120 should be held motionless at alocation, or that the orientation of the nozzle 120 and/or the injector100 should be changed.

Some or all of the components of the injector 100 may be disposed on orinside a housing (not shown). In some embodiments, the ampoule 112 andthe nozzle 120 (or subcomponents thereof) may be a disposable assemblyconfigured to be removably coupled to the actuator 110, allowing theinjector 110 to be used for multiple patients.

The actuator 110 controllably generates an injection pressure to delivera treatment through the skin to a subcutaneous treatment site of thepatient. The actuator 110 may be configured to be operated manually(such as by a user pressing a button or trigger), and/or may operateautomatically when the processor 130 determines that a treatment shouldbe delivered. In some embodiments, the processor 130 may control theoperation of the actuator 110 by allowing or disallowing an injection ata particular location or in a particular orientation. For example, theprocessor 130 may temporarily disable the actuator 110 when the nozzle120 is positioned over a location at which a maximum amount of treatmenthas already been injected, or when the nozzle 120 is not engaged againstthe treatment surface. Once the nozzle 120 has been re-positioned at asuitable location, the processor 130 may re-enable the actuator 110.

The actuator 110 may be controlled by a servo-controller (not shown),which may be a motor that employs electromagnetic or Lorentz force. Theactuator 110 may be of the type described in U.S. Pat. No. 8,740,838,titled “INJECTION METHODS USING A SERVO-CONTROLLED NEEDLE-FREEINJECTOR,” issued on Jun. 3, 2014, the contents of which are herebyincorporated by reference in their entirety for all purposes. Theprocessor 130 may obtain information from the actuator 110 during orafter each injection event indicative of a volume of treatmentdelivered, one or more depths to which the treatment was delivered, andother information regarding the injection and/or the injection profile.The processor 130 may store that treatment information in the memory180.

The ampoule 112 may taper at one end to form the nozzle 120, which is ahollow body having an inner diameter and a volume for effectivelydelivering the treatment to the subcutaneous site. Though the examplesdescribed herein use only one nozzle for ease of illustration, it willbe appreciated that a plurality of nozzles may be employed. The nozzlesmay be disposed in a grid or array pattern, in a circular shape, in aline, or in other arrangement suitable for administering treatment.

The accelerometer 140 and/or the gyroscope 150, either alone or incombination, may provide to the processor 130 information regarding theorientation (e.g., tilt) and motion/acceleration of the phone. Theinformation may relate to the instantaneous direction and magnitude ofthe orientation or motion. The accelerometer 140 and/or the gyroscope150 may be provided as part of one or more microelectromechanicalsystems (MEMS) chips or components, and in a preferred embodiment mayprovide information on movement in three dimensions. Similarly, thebarometric pressure sensor 160 may be used to measure atmosphericpressure in the ambient area around the injector 100. Information fromthe barometric pressure sensor 160 can be used to detect relativechanges in the atmospheric pressure, which may indicate that theinjector 100 has been moved vertically. This information, possibly incombination with the information from the accelerometer 140 and/or thegyroscope 150, can be used to detect and measure movement of theinjector 100 in a vertical direction.

The imaging sensor 170 (i.e., camera) may be positioned near the nozzle120 and configured and oriented to capture images of the treatmentsurface. The processor 130 may use the imaging sensor 170 to selectivelycapture images of the treatment surface periodically or upon detectionof movement, or lack of movement, of the injector 100. The processor 130may use the images to determine a current location of the nozzle 120and/or the injector 100. For example, by detecting the relative movementof one or more features (e.g., moles) in subsequent images, the relativemovement of the nozzle 120 can also be determined. In some embodiments,the features detected in the images may be grids, lines, or otherfeatures applied to the treatment surface to facilitate the use of theinjector 100. The imagine sensor 170 may further comprise a sonogramsensor configured to capture one or more ultrasound images of thetreatment surface or potential treatment sites in the skin or themuscles beneath it.

The processor 130 may correlate the injection information (e.g., volumeof an injection event) received from the actuator 110 with the locationinformation received from the accelerometer 140, the gyroscope 150, thebarometric pressure sensor 160, and/or the imaging sensor 170 todetermine how much treatment was delivered for a particular location onthe treatment surface or a particular treatment site in the body. Thisinformation may be stored in the memory 180 to create a profile of someor all of the treatment region, with the profile storing the amount oftreatment delivered at each location within the treatment region. Forexample, the memory 180 may store a two-dimensional array representingthe treatment surface, with the amount of treatment delivered at eachlocation on the treatment surface being stored at a correspondingposition in the array. In another example, the memory 180 may store athree-dimensional array representing the treatment surface as well asthe underlying potential treatment sites, with the amount of treatmentdelivered to each location being stored at a corresponding position inthe array. In such embodiments, the x- and y-axes of the array maycorrespond to a latitude and longitude position on the treatmentsurface. The z-axis may correspond to a depth to which the treatment wasinjected.

Each position in the array may correspond to an area of a givendimension on the treatment surface. For example, each position in atwo-dimensional array may correspond to an area of subcutaneous tissueof 1 mm². Similarly, each position in a three-dimensional array maycorrespond to a volume of subcutaneous tissue of 1 mm³. It will beappreciated that these dimensions are given for illustrative purposesonly, and that different dimensions may be used according to thetreatment, condition being treated, or other factors.

For each location in the array, the memory 180 may store informationincluding the amount of treatment delivered at the correspondinglocation; a remaining amount of treatment to be delivered at thecorresponding location; a minimum or maximum amount of treatment to bedelivered at the corresponding location; any information known about thelocation (e.g., the presence of any features such as moles, wrinkles,tumors, cysts, or the like); any information about previous injectionsor doses applied at the location; or other such information.

The user interface 190 may be used to guide, instruct, or otherwiseprovide information to the user (e.g., the patient or physician)regarding the use of the injector 100. Such information may be providedthrough audio, visual, and/or tactile elements of the user interface190. For example, the user interface 190 may include a display screenconfigured to display text or other indications. The user interface 190may also include a speaker configured to provide audible information tothe user, such as tones or speech. The user interface may also include atactile component configured to cause the injector 100 or componentsthereof to vibrate or buzz.

The user interface 190 may indicate that the user should move the nozzle120 to or from a particular location. For example, a visual display mayindicate that the user should move the nozzle 120 in a particularlocation on the treatment surface. The visual display may also indicatehow fast the nozzle 120 should be moved, for example, by providingfeedback on a current velocity of the nozzle 120. Where the nozzle 120is being moved too quickly, for example, the user interface 190 mayflash an indicator, buzz, or issue an audible alert for the user to movethe nozzle 120 more slowly. In some embodiments, when the nozzle 120 hasreached a location where treatment should be delivered, the userinterface 190 may indicate that the user should stop moving the nozzle120 and hold it motionless at a current location. The user interface 190may indicate that the user should adjust an orientation of the nozzle120 and/or the injector 100 by tilting or realigning the injector 100.The user interface 190 may also indicate that the user should activatethe actuator 120, if necessary. After the treatment is delivered, theuser interface 190 may indicate that the user may move the nozzle 120again.

In some embodiments, the user interface 190 may be used to assist theinjector 100 in re-locating a previous location. For example, in someembodiments a first treatment may be delivered at a first location andsubsequent locations, and a second treatment may then be delivered atthe first location and subsequent locations, making it necessary ordesirable to re-locate the first location before administering thesecond treatment. In such examples, the user interface 190 may guide theuser to move the nozzle 120 and/or the injector 100 generally through aseries of motions, such as a spiral or series of concentric circles, toorient the device by re-locating the first location.

In operation, the injector 100 is moved around the treatment surface bythe user. At each location, the injector 100 determines if an injectionhas already been delivered at that location, and if so, how much. Usingthis information, the injector 100 may determine an amount of treatmentto currently deliver at that location, or may determine that no furthertreatment should be delivered at that location. If some amount oftreatment is to be delivered, the processor 130 may cause or allow theactuator 110 to deliver the treatment, and may update the treatmentinformation for that location accordingly.

A method 200 of operating an injector (e.g., injector 100) according tosome embodiments is described with reference to FIG. 2.

Method 200 begins at step 210.

At step 220, an injector delivers a first volume of a treatment at afirst location on a surface of a body of the patient. As discussedabove, an actuator delivers the treatment through the skin of thepatient to a subcutaneous treatment site. The velocity and force of theinjection may be controlled so that the subcutaneous site may be anintradermal site, a subdermal site, or an intramuscular site. Thesubcutaneous treatment site may be located directly underneath acorresponding location on the treatment surface and accessible mostdirectly via an injection at that location and perpendicular to thetreatment surface. It will be appreciated, however, that an injectionmay be delivered to the treatment site from another location at thetreatment surface, with the injection delivered at an acute or obtuseangle to the treatment site.

At step 230, a movement of the needle-free injection device is detectedrelative to the first location. In some embodiments, the movement may bedetected from information output by one or more sensors, including anaccelerometer, gyroscope, barometric pressure sensor, camera, orotherwise. For example, an accelerometer may be included in the injectorto detect when and how much the injector is accelerating. Thisinformation may be used to determine how far the injector has beenmoved. As another example, a gyroscope may be included in the injectorto determine an orientation of the injector. For example, if the angleof a nozzle of the injector has changed due to the injector beingtilted, a different subcutaneous treatment site may be aligned with thenozzle. As another example, a barometric sensor may be included in theinjector to detect a current height (i.e., vertical position) of theinjector. This information may be used to help determine what treatmentsite is aligned with the nozzle.

As will be discussed in more detail below, an imaging sensor may also beused to detect movement by capturing images of the treatment surfaceperiodically or upon detection of movement, or lack of movement, of theinjector. A relative movement of one or more treatment surface featuresin consecutive images may indicate movement.

At step 240, the movement of the injector detected in step 230 is usedto determine a second location of the injector relative to the firstlocation. For example, by examining the information from theaccelerometer and gyroscope, it may be determined that the device movedat a known rate for a known amount of time in one or more knowndirections. This information can be used to determine the secondlocation of the injector (after or during the movement) relative to thefirst location. The second location may be determined as an offset ofthe first location, and may be expressed and/or stored as a series oftwo- or three-dimensional coordinates representing the offset distanceof the second location from the first location. In another example, thesecond location may be determined as an offset of the first location ona different coordinate scheme, such as on a polar coordinate system.

As will be discussed in more detail below, one or more images capturedthe output of the imaging sensor may be used to determine a currentlocation of the injector. For example, by detecting the relativemovement of one or more features (e.g., moles) in subsequent images, therelative movement of the nozzle can be determined.

At step 250, a second volume of the treatment to deliver at the surfaceof the body of the patient at the second location is determined. In oneexample, a memory having information about previous treatments at thesecond location may be accessed. For example, the memory may store atwo-dimensional array or matrix representing the treatment surface, withthe amount of treatment delivered at each location on the treatmentsurface being stored at a corresponding position in the array. Inanother example, the memory may store a three-dimensional array ormatrix representing the treatment surface as well as the underlyingpotential treatment sites, with the amount of treatment delivered toeach location being stored at a corresponding position in the array ormatrix. In such embodiments, the x- and y-axes of the array or matrixmay correspond to a latitude and longitude position on the treatmentsurface. The z-axis may correspond to a depth to which the treatment wasinjected.

In these examples, the location in the array or matrix corresponding tothe second location may be accessed, and a current amount of treatmentto be delivered at the second location or to a corresponding treatmentsite may be determined. For example, where no treatment has beendelivered at the second location, it may be determined that a fulllocation volume (i.e., the amount that would be injected at thatlocation as part of a larger full dose) should be delivered. Where someamount of treatment less than the full location volume has already beendelivered at the second location as part of a previous injection, it maybe determined that a lesser amount should be delivered. Where the fulllocation volume has already been delivered at the second location, itmay be determined that no further treatment should be delivered at thesecond location.

The amount of treatment to be delivered at the second location may bemade with reference to information about injections made as part of thecurrent dose being administered, as well as information about doses thatwere administered in a previous time period, including the previoushour, day, week, month, year, etc. In one example, the amount oftreatment to be delivered at the second location may be determined withreference to an amount of treatment delivered at the second locationonly as part of the current dose, which make take roughly 15 minutes toadminister. In another example, the amount of treatment to be deliveredat the second location may be determined with reference to an amount oftreatment delivered at the second location within the previousmonth—that is, an injection may be withheld at the second location whereit is determined that a full location volume was already injected thereanytime within the previous 30 days. The amount of time, or the numberof events, for which prior injection information is relevant may beconfigured by the user, or may be configured automatically according tothe type of treatment and the dosing information.

It will be appreciated that because the injector may be configured todeliver treatment to different subcutaneous depths, the injector maytrack multiple volumes of treatment delivered at a single location tomultiple treatment sites of varying depths. For example, the injectormay be configured to deliver a certain volume to an intramuscular siteunderneath a treatment surface location on a first pass over thelocation, and on subsequent passes may deliver other volumes tosubdermal and intradermal sites underneath the treatment surfacelocation. In this manner, treatment can be vertically “stacked” withinthe subcutaneous layers.

Where it is determined that no treatment is to be delivered at thesecond location, the actuator may be temporarily disabled for a certainamount of time (e.g., enough time until the second location is able toreceive further treatment), or until the injector has been moved toanother location away from the second location.

At step 260, the injector delivers the second volume of the treatment atthe second location on the surface of the body of the patient in muchthe same way as in step 220.

The exemplary method 200 describes injecting two volumes of treatmentfor ease of illustration, but it will be appreciated that the number ofinjections may typically be greater, such that the combined volume ofall of the injections is substantially equal to the full dose amount. Insome embodiments, therefore, some of the steps of method 200 may berepeated many (e.g., 50-100) times.

At step 270, method 200 ends.

As discussed above, an imaging sensor (i.e., a camera) may be used insome embodiments to capture one or more images of the treatment surface.The images may be used to determine or confirm a location of theinjector relative to the treatment surface.

A method 300 of determining a location of the injector from one or moreimages according to some embodiments is described with reference to FIG.3.

Method 300 begins at step 310.

At step 320, a first image of the surface of the body of the patient iscaptured, and at step 330, the first location is identified in the firstimage. In particular, the position of the first location in the imagemay be fixed and known, because the location of the nozzle relative tothe camera may be fixed. In some embodiments, therefore, an appearanceof the pixels corresponding to the first location may be determined,such as their color values and arrangement.

At step 340, a second image of the surface of the body of the patient iscaptured, and at step 350, the first location is identified in thesecond image. In particular, the second image may be examined for acollection of pixels having the appearance of the pixels correspondingto the first location in the first image. If those pixels are located inthe second image, their location in the second image can be expected tocorrespond to the first location.

By determining the relative movement of the first location between thefirst image and the second image, a relative amount of movement of theinjector can also be determined. This relative amount of movement can beused to determine or confirm the second location of the injector.

The exemplary method 300 describes capturing two images for ease ofillustration, but it will be appreciated that the number of images maytypically be greater as the injector is moved around the treatmentsurface.

Method 300 ends at step 360.

As discussed above, injectors in the present embodiments may incorporateuser interfaces that instruct, guide, or otherwise provide the user withinformation regarding moving and positioning the injector on thetreatment surface. A use case involving such user interfaces isdiscussed with reference to FIGS. 4A-4D.

In FIG. 4A, the injector is at a first location. The user interface 400indicates that the user should begin moving the nozzle of the injectorto another location. In some embodiments, the user interface 400 maydisplay a directional indicator showing in which direction the nozzleshould be moved. In other embodiments, a heatmap or other representationof the treatment surface or portions thereof may be displayed, withregions suitable for receiving injections as part of the current dosebeing shown in a corresponding color.

In FIG. 4B, the user has begun moving the injector, but is moving it tooquickly. The user interface 400 indicates that the user should move theinjector more slowly. In some embodiments, visual indicators 410, 420may flash or otherwise visually indicate that the injector is moving atan unsuitable speed. By contrast, where the injector is motionless, oris being moved at an appropriate speed, the visual indicators 410, 420may flash in a different pattern, or may be solidly on or off.

In FIG. 4C, the injector has reached the second location, and the userinterface 400 indicates that the user should hold the injector steady toprepare for an injection. As a safety measure, the injector may disallowinjections while the injector is moving above a threshold amount.

In FIG. 4D, the injector has determined that the nozzle needs to bere-oriented to administer the injection, so the user interface 400indicates that the user should tilt the injector. In some embodiment, arepresentation of a bubble level, or other indicator of angle, may bedisplayed to assist the user in achieving the proper angle. In someembodiments, a directional indicator may show in which direction theinjector should be tilted, and by how much.

Once the injector is properly aligned, the user interface 400 mayindicate that the user may administer the injection (e.g., bymanipulating a trigger of the actuator), or the actuator may beconfigured to deliver the injection automatically when an appropriatelocation is reached and the appropriate orientation is achieved. Afterthe injection is administered, the user interface 400 may return to theview in FIG. 4A, and indicate that the user may move the injector toanother location.

In some embodiments, the injector may be an injector system for use in amedical setting, such as a physician's office. In such embodiments, thecomponents of the injector system may be spread among a number ofassemblies or housings. One or more components of the injector system(e.g., the ampoule and the nozzle) may be designed to be formed as adisposable single-dose assembly, allowing for re-use of the injectorsystem with new, sanitized components for each patient.

An injector system 500 according to one or more embodiments is shown inFIGS. 5A and 5B. Except as described herein, the components describedhere function similarly to the counterpart components described above.

In the injector system 500, a number of components are included in aninjector assembly 122, including an accelerometer 140, a gyroscope 150,a barometric sensor 160, an imaging sensor 170 (i.e., a camera), and auser interface 190. The injector assembly 122 is connected by means ofone or more connectors 126 to other components in a housing 510, whichmay contain an actuator 110, a processor 130, and a memory 180. The oneor more connectors 126 may be cables configured to allow the componentsin the injector assembly 122 to exchange information with the componentsin the housing 510.

In some embodiments, the injector assembly 122 is configured to receivea single-dose assembly 114 that includes a nozzle 120 connected to anampoule 112 configured to connect to the actuator 130 in the housing510. The injector assembly 122 may have a nozzle barrel 124 shaped toreceive the nozzle 120 of the single-dose assembly 114 and hold thenozzle 120 in an orientation suitable for administering injectionsaccording to the embodiments described herein. Some or all of theampoule 112 may contain one or more doses of a treatment to beadministered through the nozzle 120 by the actuator 130. The nozzle 120may be welded or otherwise sealed to the ampoule 112, making thesingle-dose assembly 114 a unitary disposable component suitable forsale separate from the injector system 500, as shown in FIG. 5B.

In other embodiments, the injector may be embodied in a handheld device.It will be appreciated that the embodiments described herein have abroad range of medical applications (including dental treatments) aswell as cosmetic procedures.

As discussed above, aspects and functions disclosed herein may beimplemented as hardware or software on one or more of these computersystems. There are many examples of computer systems that are currentlyin use. These examples include, among others, network appliances,personal computers, workstations, mainframes, networked clients,servers, media servers, application servers, database servers and webservers. Other examples of computer systems may include mobile computingdevices, such as cellular phones and personal digital assistants, andnetwork equipment, such as load balancers, routers and switches.Further, aspects may be located on a single computer system or may bedistributed among a plurality of computer systems connected to one ormore communications networks.

For example, various aspects and functions may be distributed among oneor more computer systems configured to provide a service to one or moreclient computers. Additionally, aspects may be performed on aclient-server or multi-tier system that includes components distributedamong one or more server systems that perform various functions.Consequently, examples are not limited to executing on any particularsystem or group of systems. Further, aspects may be implemented insoftware, hardware or firmware, or any combination thereof. Thus,aspects may be implemented within methods, acts, systems, systemelements and components using a variety of hardware and softwareconfigurations, and examples are not limited to any particulardistributed architecture, network, or communication protocol.

The computer devices described herein are interconnected by, and mayexchange data through, a communication network. The network may includeany communication network through which computer systems may exchangedata. To exchange data using the network, the computer systems and thenetwork may use various methods, protocols and standards, including,among others, Fibre Channel, Token Ring, Ethernet, Wireless Ethernet,Bluetooth, Bluetooth Low Energy (BLE), IEEE 802.11, IP, IPV6, TCP/IP,UDP, DTN, HTTP, FTP, SNMP, SMS, MMS, SS7, JSON, SOAP, CORBA, REST andWeb Services. To ensure data transfer is secure, the computer systemsmay transmit data via the network using a variety of security measuresincluding, for example, TSL, SSL or VPN.

The computer systems include processors that may perform a series ofinstructions that result in manipulated data. The processor may be acommercially available processor such as an Intel Xeon, Itanium, Core,Celeron, Pentium, AMD Opteron, Sun UltraSPARC, IBM Power5+, or IBMmainframe chip, but may be any type of processor, multiprocessor orcontroller.

A memory may be used for storing programs and data during operation ofthe device. Thus, the memory may be a relatively high performance,volatile, random access memory such as a dynamic random access memory(DRAM) or static memory (SRAM). However, the memory may include anydevice for storing data, such as a disk drive or other non-volatilestorage device. Various examples may organize the memory intoparticularized and, in some cases, unique structures to perform thefunctions disclosed herein.

The devices may also include one or more interface devices such as inputdevices and output devices. Interface devices may receive input orprovide output. More particularly, output devices may render informationfor external presentation. Input devices may accept information fromexternal sources. Examples of interface devices include keyboards, mousedevices, trackballs, microphones, touch screens, printing devices,display screens, speakers, network interface cards, etc. Interfacedevices allow the computer system to exchange information andcommunicate with external entities, such as users and other systems.

Data storage may include a computer readable and writeable nonvolatile(non-transitory) data storage medium in which instructions are storedthat define a program that may be executed by the processor. The datastorage also may include information that is recorded, on or in, themedium, and this information may be processed by the processor duringexecution of the program. More specifically, the information may bestored in one or more data structures specifically configured toconserve storage space or increase data exchange performance. Theinstructions may be persistently stored as encoded signals, and theinstructions may cause the processor to perform any of the functionsdescribed herein. The medium may, for example, be optical disk, magneticdisk or flash memory, among others. In operation, the processor or someother controller may cause data to be read from the nonvolatilerecording medium into another memory, such as the memory, that allowsfor faster access to the information by the processor than does thestorage medium included in the data storage. The memory may be locatedin the data storage or in the memory, however, the processor maymanipulate the data within the memory, and then copy the data to thestorage medium associated with the data storage after processing iscompleted. A variety of components may manage data movement between thestorage medium and other memory elements and examples are not limited toparticular data management components. Further, examples are not limitedto a particular memory system or data storage system.

Various aspects and functions may be practiced on one or more computershaving a different architectures or components than that shown in theFigures. For instance, one or more components may include speciallyprogrammed, special-purpose hardware, such as for example, anapplication-specific integrated circuit (ASIC) tailored to perform aparticular operation disclosed herein. While another example may performthe same function using a grid of several general-purpose computingdevices running MAC OS System X with Motorola PowerPC processors andseveral specialized computing devices running proprietary hardware andoperating systems.

One or more components may include an operating system that manages atleast a portion of the hardware elements described herein. A processoror controller may execute an operating system which may be, for example,a Windows-based operating system, such as, Windows NT, Windows 2000(Windows ME), Windows XP, Windows Vista or Windows 7 operating systems,available from the Microsoft Corporation, a MAC OS System X operatingsystem available from Apple Computer, an Android operating systemavailable from Google, one of many Linux-based operating systemdistributions, for example, the Enterprise Linux operating systemavailable from Red Hat Inc., a Solaris operating system available fromOracle Corporation, or a UNIX operating systems available from varioussources. Many other operating systems may be used, and examples are notlimited to any particular implementation.

The processor and operating system together define a computer platformfor which application programs in high-level programming languages maybe written. These component applications may be executable,intermediate, bytecode or interpreted code which communicates over acommunication network, for example, the Internet, using a communicationprotocol, for example, TCP/IP. Similarly, aspects may be implementedusing an object-oriented programming language, such as .Net, SmallTalk,Java, C++, Ada, or C# (C-Sharp). Other object-oriented programminglanguages may also be used. Alternatively, functional, scripting, orlogical programming languages may be used.

Additionally, various aspects and functions may be implemented in anon-programmed environment, for example, documents created in HTML, XMLor other format that, when viewed in a window of a browser program,render aspects of a graphical-user interface or perform other functions.Further, various examples may be implemented as programmed ornon-programmed elements, or any combination thereof. For example, a webpage may be implemented using HTML while a data object called fromwithin the web page may be written in C++. Thus, the examples are notlimited to a specific programming language and any suitable programminglanguage could be used. Thus, functional components disclosed herein mayinclude a wide variety of elements, e.g. executable code, datastructures or objects, configured to perform described functions.

What is claimed is:
 1. A needle-free device for administeringsubcutaneous treatment to a patient comprising: an actuator configuredto deliver a plurality of volumes of a treatment at a plurality oflocations on a surface of a body of the patient; at least one sensorconfigured to detect a movement of the needle-free device from a firstlocation on the surface of the body of the patient to a second locationon the surface of the body of the patient; and a processor configured todetermine, from the movement of the needle-free device relative to thefirst location on the surface of the body, the second location on thesurface of the body of the device relative to the first location, anddetermine a volume of the plurality of volumes of the treatment todeliver at the surface of the body of the patient at the secondlocation.
 2. The device of claim 1, further comprising a nozzle, whereinthe actuator delivers the plurality of volumes of the treatments throughthe nozzle.
 3. The device of claim 1, wherein the actuator comprises atleast one of a Lorentz motor and an electromagnetic motor.
 4. The deviceof claim 1, wherein the processor is further configured to determine thevolume of the treatment to deliver at the surface of the body of thepatient with reference to a previous treatment volume delivered at asubcutaneous treatment site adjacent the second location.
 5. The deviceof claim 4, wherein the processor is further configured to determine,responsive to the previous treatment volume exceeding a predeterminedvalue, that no treatment should be delivered to the subcutaneoustreatment site.
 6. The device of claim 5, wherein the processor isfurther configured to prevent the actuator from delivering the treatmentto the subcutaneous treatment site.
 7. The device of claim 1, furthercomprising a camera configured to capture a plurality of images of thesurface of the body of the patient.
 8. The device of claim 7, whereinthe processor is further configured to determine the second location ofthe needle-free device relative to the first location with reference toat least one of the plurality of images.
 9. The device of claim 8,wherein the processor is further configured to: identify, in a firstimage of the plurality of images, the first location; and identify, in asecond image of the plurality of images, the first location.
 10. Thedevice of claim 9, wherein the processor is further configured toidentify, in the second image of the plurality of images, the secondlocation.
 11. The device of claim 10, wherein the volume is determinedwith reference to a value determined from at least one of the firstimage and the second image.
 12. The device of claim 1, wherein the atleast one sensor is at least one of an accelerometer, a gyroscope, and abarometric sensor.
 13. The device of claim 1, further comprising amemory, wherein the processor is further configured to store in thememory a first location value corresponding to the first location and asecond location value corresponding to the second location.
 14. Thedevice of claim 13, wherein the processor is further configured to storein the memory a plurality of values corresponding to a volume oftreatment delivered at each of the first location and the secondlocation.
 15. The device of claim 14, wherein the processor isconfigured to store the plurality of values in a representation of anarray.
 16. The device of claim 1, further comprising a plurality ofnozzles, wherein the actuator delivers the plurality of volumes of thetreatments through the plurality of nozzles.
 17. The device of claim 1,further comprising a user interface configured to provide an indicationthat the needle-free device should be moved from one of the firstlocation and the second location.
 18. The device of claim 17, whereinthe user interface is further configured to provide an indication of avelocity at which the needle-free device should be moved from the firstlocation to the second location.